Wireless Cardiorespiratory Monitor for Neonates

新生儿无线心肺监护仪

• 批准号: 6788488
• 负责人: MICHAEL JOHN SCIARRA
• 金额: $ 10.19万
• 依托单位: PGS MED RESEARCH & ELECTRONIC DESIGN,LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-24 至 2005-05-23
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6788488
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; bradycardia; clinical biomedical equipment; clinical research; heart rate; human subject; monitoring device; neonatal intensive care; newborn human (0-6 weeks); portable biomedical equipment; premature infant human; respiratory airflow measurement; respiratory disorder diagnosis

With improvements in neonatal and reproductive medicine, greater numbers of premature neonates are surviving that require hospital and home cardiorespiratory monitoring. Investigators propose a method for acquiring an infant's heart rate at the abdomen without the use of electrodes. This new method will be combined with a previously developed respiratory rate sensor. Both sensors will be integrated into a single belt, worn at the abdomen, and will each transmit cardiorespiratory data wirelessly to a bedside monitor. Following laboratory testing, this integrated monitor will be evaluated in a clinical setting at the Neonatal Intensive Care Unit (NICU) at Children's National Medical Center for reliability, safety, and general acceptability. This low cost, electrodeless, and wireless design could 1) replace aging monitoring equipment at Level I/II care nurseries, in the home, and in neonatal transport equipment at dramatically reduced costs; 2) introduce eardiorespiratory monitoring into areas of neonatal care where it was previously cost prohibitive; and 3) improve the ease and comfort by which infants, parents, and caregivers interact. Phase II goals of this research are to: 1) adapt the respiratory sensor to distinguish between central, obstructed, or mixed apnea; 2) implement apnea and bradycardia event detection; 3) explore implementation of an oximetric sensor; and 4) expand the validation study beyond the NICU into other areas of neonatal care including home monitoring through multi-center studies. The wireless and disposable features of this technology define this as a value-added niche product that may appeal to larger competitors desiring to improve their market share by offering inexpensive, easy to use infant monitoring that prevents cross-contamination.

随着新生儿和生殖医学的进步，越来越多的早产儿存活下来，需要医院和家庭心肺监测。研究人员提出了一种无需使用电极即可在腹部获取婴儿心率的方法。这种新方法将与之前开发的呼吸频率传感器相结合。两个传感器将集成到一条腰带中，佩戴在腹部，并且每个传感器都会将心肺数据无线传输到床边监视器。经过实验室测试后，该集成监测仪将在国家儿童医疗中心新生儿重症监护室 (NICU) 的临床环境中进行可靠性、安全性和普遍可接受性评估。这种低成本、无电极和无线设计可以 1) 取代 I/II 级护理托儿所、家庭和新生儿运输设备中的老化监测设备，并大幅降低成本； 2) 将心肺监测引入到以前成本高昂的新生儿护理领域； 3) 提高婴儿、父母和护理人员互动的轻松度和舒适度。这项研究的第二阶段目标是：1）调整呼吸传感器以区分中枢性呼吸暂停、阻塞性呼吸暂停或混合性呼吸暂停； 2) 实现呼吸暂停和心动过缓事件检测； 3）探索血氧传感器的实现； 4) 将验证研究从 NICU 扩展到新生儿护理的其他领域，包括通过多中心研究进行家庭监测。该技术的无线和一次性特性将其定义为一项增值服务 这种利基产品可能会吸引较大的竞争对手，这些竞争对手希望通过提供廉价、易于使用的婴儿监控来防止交叉污染，从而提高其市场份额。